Clinical Research Coordinator

Mckesson Corporation; USA; Vor Ort; USD 79.000 - 90.000; Vollzeit

Zusammenfassung

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) research. The role oversees clinical operations of the blood cancer program, including enrollment, regulatory compliance, quality, and site operations.

You will enroll patients on trials, verify informed consent, manage data entry, and ensure protocol adherence while coordinating with monitors and study teams to ensure high-quality data and patient safety.

Qualifikationen

• Oncology experience in clinical trials or hematology/oncology settings.
• Knowledge of medical and research terminology.
• Familiarity with FDA CFR and GCP guidelines.
• Experience with clinical research processes and data collection.

Aufgaben

• Enrol patients onto clinical trials through recruitment, screening, enrollment, treatment and follow-up as per protocol.
• Review study design and inclusion/exclusion criteria with physicians and patients.
• Ensure protection of patients by verifying informed consent and protocol adherence.
• Collect and enter data into study CRFs or EDC systems within required timelines.
• Maintain data integrity via source document review and monitoring for missing or implausible data.
• Create study-specific source documentation tools when not provided by sponsor.
• Generate and track drug shipments, lab kits, and supplies.
• Document protocol requirements per SOPs and site work instructions.
• Track and report adverse events, SAEs, protocol waivers and deviations.
• Maintain regulatory documents, consent forms, source documentation and study communications.
• Coordinate regular site research meetings and attend on-site investigator meetings and calls.

Kenntnisse

Oncology experience

Public presentation skills

Multiple priorities management

Medical terminology

FDA CFR & GCP knowledge

Ausbildung

Associate's Degree

Bachelor's Degree preferred

ACRP or CCRP certification

RN or LPN preferred

Jobbeschreibung

It's More Than a Career, It's a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

As the Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) research you are responsible for overall clinical operations of the facility's blood cancer research program including enrollment, regulatory, quality, and site operations.

• You will support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
• You will review the study design and inclusion/exclusion criteria with physicians and patients
• You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements
• You will collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines
• You will ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data
• You will create study specific tools for source documentation when not provided by sponsor
• You will generate and track drug shipments, lab kits, and other supplies
• You will be responsible for accurate and complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs)
• You will track and report adverse events, serious adverse events, protocol waivers, and deviations
• You will maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications
• You will coordinate regular site research meetings
• You will attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, as required and you will work closely with monitors, study teams and site staff to ensure quality study data
• You will communicate site status through a weekly activity report to appropriate site/management colleagues

You should have:

• An Associate's Degree, preferably a Bachelor's Degree
• Knowledge of medical and research terminology
• Knowledge of FDA Code of Federal Regulations and GCP
• Knowledge of the clinical research processes
• Public presentation skills The ability to manage multiple ongoing priorities and projects with a diverse team of professionals
• At least one year of oncology experience, preferably in hematology/oncology and/or transplant
• At least one year of experience in a clinical research setting
• At least one year of experience managing blood cancer and/or BMT clinical trials is preferred
• Research certification (ACRP or CCRP) is preferred
• RN or LPN is preferred

Salary range $79,000 - $90,000

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information reg